Device and method for through the scope endoscopic hemostatic clipping

ABSTRACT

Medical device used to cause hemostasis of blood vessels using a clip arrangement delivered to a target region through an endoscope. Method for using the device to cause hemostasis of a blood vessel through an endoscope. Medical device including a reversibly closeable clip, a locking arrangement, a control wire, a sheath, and a handle with an actuating trigger. Through the endoscope, hemostatic clipping device that is fully reversible and lockable. Hemostatic clip that reversibly targets and clips bleeding ulcers.

FIELD OF THE INVENTION

[0001] The present invention relates to compression clips, and morespecifically, to compression clips used to cause hemostasis of bloodvessels located along the gastrointestinal tract delivered to a targetsite through an endoscope.

BACKGROUND

[0002] Gastrointestinal (“GI”) bleeding is often associated with pepticulcer disease (PUD) and can be fatal if not treated immediately.Hemorrhaging is the most dangerous procedure with which aGastro-Intestinal Endoscopist has to deal. It is his/her only unplanned,emergency procedure where time is critical in determining the outcome.It is also the one problem the Endoscopist faces that is generally notan outpatient procedure. A bleeding PUD can be a critical clinical eventas there is internal hemorrhaging. Ulcers are classified from clean toactive spurting bleeding. The most worrisome are active bleeders andvisible vessels. Untreated visible vessels are likely to bleed.

[0003] Suspected bleeding PUD patients can be diagnosed and treatedendoscopically in an emergency room, an ICU or the GI suite. Surgerygenerally results in higher cost, morbidity and mortality thanendoscopy. Therefore, laparoscopy or open surgery is not preferredunless there is no endoscopic alternative or endoscopy has failed. Ifthe diseased tissue is beyond repair, a surgical gastric resection maybe performed.

[0004] Currently, the endoscopist has two commonly used treatments andsome lesser used therapies to achieve hemostasis of the ulcer. The mostwidely used treatments are thermal therapy and injection therapy. Someof the less common options are Olympus Endoclips, lasers and argonplasma cautery.

[0005] With thermal therapy, a catheter with a rigid heating element tipis passed through the working channel of an endoscope after the bleed isvisualized and diagnosed. After the rigid catheter tip has exited thescope, the scope is manipulated to press the tip against the bleed site.Thermal power is applied, either through a resistive element in the tipor by applying RF energy through the tissue, thus desiccating andcauterizing the tissue. The combination of the tip compressing thetissue/vessel and the application of heat theoretically welds the vesselclosed.

[0006] Although thermal treatment is fairly successful in achievinghemostasis, it often takes more than one attempt (irrigation is appliedafter the initial treatment to see if hemostasis has occurred) and thereis frequent re-bleeding. Generally several pulses of energy are appliedduring each attempt. If early re-treatment is needed, there is a risk ofperforation with the heat probe. Another disadvantage is that both typesof thermal therapy require a specialized power generator and theequipment can be expensive.

[0007] With injection therapy, a catheter with a distally extendablehypo needle is passed through the working channel of the endoscope afterthe bleeding has been visualized and diagnosed. Once the catheter tiphas exited the scope, the scope is manipulated to the bleed site, theneedle is extended remotely and inserted into the bleed site. Avasoconstricting (narrowing of blood vessels) or sclerosing (causing ahardening of tissue) drug is then injected through the needle. Multipleinjections in and around the bleeding site are often needed, untilhemostasis has been achieved. As with thermal therapy, re-bleeding isalso a problem.

[0008] The treatment used in any specific instance is highly dependenton geographic region. In some regions, especially in the United States,injection therapy is often combined with thermal treatment since neithertherapy is completely effective alone.

[0009] The primary success rate of endoscopic treatment is about 90%.The other cases are usually referred to surgery. All identified ulcersmay re-bleed at a later time, but the re-bleed rate for endoscopicallytreated active bleeds and a visible vessel is 10-30%. Even with theintroduction of new treatments and devices, these rates have notimproved significantly in decades. Surgery's short and long-term successfor permanent hemostasis is virtually 100%.

[0010] Surgery has a higher success rate because the bleeding site iscompressed mechanically, causing better hemostasis. Using devices suchas clamps, clips, staples, sutures (i.e. devices able to applysufficient constrictive forces to blood vessels so as to limit orinterrupt blood flow), the bleeding vessel is ligated or the tissuearound the bleed site is compressed, ligating all of the surroundingvessels.

[0011] An existing device that incorporates the advantages of surgeryinto a less-invasive endoscopic procedure is the Olympus EndoClip. Thegoal of the device is to pinch the bleeding vessel to create hemostasis.The problem with this device is that once jaw closure begins, it is notpossible to reopen them, and the endoscopist is committed to firing theclip. In other words, jaw closure is not reversible. Because the vesselis frequently difficult to see, often several clips must be deployed inorder to successfully pinch the vessel and achieve hemostasis.Additionally, the Olympus EndoClip is a semi-reusable device, causingthe performance of the device to degrade with use.

SUMMARY OF THE INVENTION

[0012] The present invention provides medical devices for causing thehemostasis of blood vessels located along the gastrointestinal tract.The goal of the invention is to give the endoscopist a technique anddevice which: 1) has a success rate in line with the surgical option; 2)is easier to set-up than the Olympus EndoClip; and 3) is easier todeploy than the Olympus EndoClip. The design intent is to eliminatesurgery and its associated mortality and morbidity.

[0013] The medical devices of the present invention include: acompression clip used to cause hemostasis of blood vessels and amechanism for deploying the clip that includes an arrangement forclosing the clip and for reversing the closing process to reopen theclip after closure has begun. Embodiments of the invention may include alock arrangement for locking the clip closed; a control wire connectedto the clip and able to be disconnected from the clip; an axially rigidsheath enclosing the control wire and communicating a compressive forceopposing a tensile force of the control wire; a handle connected to theaxially rigid sheath; and/or a trigger enclosed within the handle andengaging the control wire to close and lock the clip and to uncouple thecontrol wire from the clip.

[0014] There are several key advantages of the invention disclosed hereover existing devices. The device's ability to repeatedly open and closethe clip until the desired tissue pinching is accomplished will lead toa quicker procedure, requiring less clips to be deployed, with a highersuccess rate. In particular embodiments, this higher success rate willbe improved even more due to the device's ability to be easily rotatedso that the clip legs can be adjusted relative to the bleeding vessel.In particular embodiments, the time required to perform the overallprocedure will also be further reduced due to the fact that the deviceis completely set up, with the clip already attached to the deliverydevice, unlike the competitive device. A more robust delivery device mayallow a larger, stronger clip to be delivered. Combinations of thesefeatures will provide for a device that is easier to use.

[0015] Another advantage inherent to particular embodiments of thisdesign is the feature of being completely disposable. The competitivedevice, the Olympus EndoClip, uses a “semi-reusable” delivery device,capable of firing several clips before it fails. This causes thedevice's functionality to degrade over the course of its use, until itis no longer able to deploy a clip. The competitive delivery device mustbe loaded manually, which is cumbersome to the operator andtime-consuming, especially in the context of an unplanned emergencyprocedure. The “single-use” (disposable) embodiments of the inventiondisclosed here would function the same with each clip, in eachprocedure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016]FIG. 1 is an enlarged partial view of a first embodiment of themedical device of the present invention.

[0017]FIG. 2 is an enlarged partial view of the distal end of theembodiment of FIG. 1.

[0018]FIG. 3 is an enlarged view of the clip of the embodiment of FIG.1.

[0019]FIG. 4 is an enlarged view of the lock sleeve of the embodiment ofFIG. 1.

[0020]FIG. 5 is an enlarged view of the S-hook of the embodiment of FIG.1.

[0021]FIG. 6 is an enlarged partial view of the control wire, retainer,and clip of the embodiment of FIG. 1.

[0022]FIG. 7 is an enlarged partial view of the handle of the embodimentof FIG. 1.

[0023]FIG. 8A is an enlarged partial view of the distal end of anotherembodiment of the medical device of the present invention.

[0024]FIG. 8B is an enlarged partial end view of the embodiment of FIG.8A.

[0025]FIG. 8C is an enlarged partial view of a clip leg of theembodiment of FIG. 8A.

[0026]FIG. 8D is an enlarged partial view of a clip locking mechanism ofthe embodiment of FIG. 8A.

[0027]FIG. 8E is an enlarged partial view of a clip locking mechanismand clip legs of the embodiment of FIG. 8A.

[0028]FIG. 8F shows enlarged partial side views of various embodimentsof clip leg shapes available for use in the medical device of thepresent invention.

[0029]FIG. 8G shows enlarged partial end views of various embodiments ofclip leg shapes available for use in the medical device of the presentinvention.

[0030]FIG. 9A is an enlarged partial view of the distal end of anotherembodiment of the medical device of the present invention.

[0031]FIG. 9B is an enlarged partial view of the embodiment of FIG. 9Abeing deployed.

[0032]FIG. 10A is an enlarged partial view of another embodiment of themedical device of the present invention.

[0033]FIG. 10B is an enlarged partial view of the embodiment of FIG. 10Abeing deployed.

[0034]FIG. 11 is an enlarged partial view of another embodiment of themedical device of the present invention.

[0035]FIG. 12A is an enlarged partial view of another embodiment of themedical device of the present invention showing the clip in an openposition.

[0036]FIG. 12B is an enlarged partial view of the embodiment of FIG. 12Ashowing the clip in a closed position.

[0037]FIG. 13A is an enlarged partial view of another embodiment of themedical device of the present invention showing the clip in a closedposition prior to disconnecting the clip.

[0038]FIG. 13B is an enlarged partial view of the distal end of theembodiment of FIG. 13A showing the clip in a closed position afterdisconnecting the clip.

[0039]FIG. 13C is an enlarged partial view of the embodiment of FIG. 13Ashowing the clip in a closed position after disconnecting the clip.

[0040]FIG. 14A is an enlarged partial view of another embodiment of themedical device of the present invention.

[0041]FIG. 14B is an enlarged partial side view of the embodiment ofFIG. 14A.

[0042]FIG. 14C is an enlarged partial view of the distal end of themedical device of the embodiment of FIG. 14A after the clip has beenreleased.

[0043]FIG. 15A is an enlarged partial view of another embodiment of themedical device of the present invention.

[0044]FIG. 15B is an enlarged partial view of the clip of the embodimentof FIG. 15A in a closed position.

[0045]FIG. 15C is an enlarged partial view of the clip of the embodimentof FIG. 15A in an open position.

[0046]FIG. 15D is an enlarged partial view of the distal end of themedical device of the embodiment of FIG. 15A after the clip has beenreleased.

[0047]FIG. 16A is an enlarged partial view of another embodiment of themedical device of the present invention.

[0048]FIG. 16B is an enlarged partial close-up side view of the end of aclip leg of the embodiment of FIG. 16A.

[0049]FIG. 16C is an enlarged partial close-up edge view of the end of aclip leg of the embodiment of FIG. 16A.

[0050]FIG. 16D is an enlarged partial view of the embodiment of FIG. 16Awith the clip in an open position.

[0051]FIG. 16E is an enlarged partial view of the embodiment of FIG. 16Awith the clip in a closed position.

[0052]FIG. 17A is an enlarged partial view of another embodiment of themedical device of the present invention.

[0053]FIG. 17B is an enlarged partial view of the embodiment of FIG.17A, showing the clip in an open position.

[0054]FIG. 18A is an enlarged view of clip legs of another embodiment ofthe medical device of the present invention.

[0055]FIG. 18B is an enlarged partial view of an embodiment of themedical device of the present invention using the clip legs of FIG. 18A.

[0056]FIG. 18C is an enlarged partial view of the embodiment of FIG.18B, showing the clip in a closed position.

[0057]FIG. 18D is an enlarged edge view of the clip of the embodiment ofFIG. 18B.

[0058]FIG. 18E is an enlarged partial end view of the embodiment of FIG.18B.

[0059]FIG. 18F is an enlarged partial side view of the embodiment ofFIG. 18B.

[0060]FIG. 19A is an enlarged partial edge view of another embodiment ofthe medical device of the present invention.

[0061]FIG. 19B is an enlarged partial side view of the embodiment ofFIG. 19A.

[0062]FIG. 19C is an enlarged partial view of a clip leg of theembodiment of FIG. 19A.

[0063]FIG. 20A is an enlarged partial end view of another embodiment ofthe medical device of the present invention.

[0064]FIG. 20B is an enlarged partial side view of the embodiment ofFIG. 20A.

[0065]FIG. 20C is a side-by-side comparison of two parts of theembodiment of FIG. 20A.

[0066]FIG. 21 is an enlarged partial view of the distal end of anotherembodiment of the medical device of the present invention.

DETAILED DESCRIPTION

[0067] In a first embodiment of the invention as shown in FIG. 1,medical device 100 includes a clip 101 having first clip leg 102 andsecond clip leg 103. Clip leg 102 has at least one lock hole 104 thereinof any suitable shape (e.g. circular, rectangular, square, etc.).Likewise, clip leg 103 has at least one lock hole 105 therein of anysuitable shape. Clip 101 is further characterized by a cut-out 106 onthe proximal end. J-hook 107 is inserted into cut-out 106. J-hook 107 isformed on the distal terminal end of control wire 108. A retainerrelease 109 is formed by bends in the control wire 108, the bends formedproximally from the j-hook 107. The control wire 108 is enclosed withinsheath 111 proximally from the retainer release 109. Retainer 110 iscoupled to control wire 108 and engages lock sleeve 113. Retainerrelease 109 acts to disengage retainer 110 from lock sleeve 113 when atensile force applied to control wire 108 is sufficient to cause suchdisengagement. An outer sleeve 112 is connected on the distal side ofsheath 111, and lock sleeve 113 is connected to a distal side of outersleeve 112. Lock sleeve 113 incorporates lock pawl 114, which engageslock hole 104 in clip leg 102, and lock pawl 115, which engages lockhole 105 in clip leg 103.

[0068] The clip 101 is a deformable, multi-legged, grasping deviceattached to the distal portion of a flexible shaft (the sheath 111) viaa frangible link (the j-hook 107). The flexible shaft is connected atits proximal end to a handle (FIG. 7), the handle analogous to biopsyforceps. A semi-rigid wire (the control wire 108), which is routed fromthe handle to the clip 101, acts as a means of actuating the clip 101between the open and closed position. The clip 101 can be actuatedbetween the open and closed position multiple times as long as the lockholes 104 and 105 do not become engaged with the lock pawls 114 and 115in the lock sleeve 113. Once the operator decides the clip 101 should bepermanently deployed, the handle can be fully actuated, which causes theretainer release 109 to pull the retainer 110 free from the outer sleeve112 and lock sleeve 113. After the retainer 110 is released, increasingforce will begin straightening the j-hook 107. The j-hook 107 is thenpulled from the cut-out 106 on the proximal side of clip 101. At thispoint, the retainer 110 and control wire 108 are no longer attached tothe distal portion of the device (the clip 101 and lock sleeve 113) andthe delivery device (e.g. an endoscope, not shown) can be removed whileleaving the clip 101 (with lock sleeve 113) in place.

[0069] The sheath 111 serves three key functions in this embodiment. Inits primary function it acts as a housing for the control wire 108. Inthis function the sheath 111 supplies a resistive, compressive forceopposite the tensile force applied to the control wire 108, via thehandle, as the lever (FIG. 7) in the handle is moved to close the clip101. The forces reverse when the lever is moved in the oppositedirection, and the control wire 108 is compressed to push the clip 101forward. In this function, the combination of control wire 108 andsheath 111 act as a simple push-pull, cable actuation mechanism.

[0070] In the secondary function of sheath 111, it acts as a means bywhich the clip 101 can be easily rotated. Ideally this rotation would beof a ratio of 1:1. In other words, one complete rotation of the sheath111 at the proximal end would translate to one complete rotation of theclip 101. This rotation however, depends on several factors. Therelationship of the outside diameter of sheath 111 to the insidediameter of the working channel (not shown) of the endoscope (notshown), is one factor. Another factor is the amount of friction betweenthe sheath 111 and the working channel caused by the path of theendoscope in the anatomy. Because these factors vary from endoscope toendoscope, and patient to patient, the rotation ratio will not always bethe same. This ease of rotation is a key function and benefit of thisembodiment in that it allows relatively precise orientation of the clip101 to the vessel. Depending on the exact construction of the sheath111, and the other factors just listed, rotation of the device may bedifferent in one direction of rotation versus the other direction. Bytaking advantage of the mechanical properties of the sheath 111, thisembodiment accomplishes rotation without the need for additional handlecomponents. Eliminating the need for such components will: reduce theoverall cost of the device; simplify how the device is operated; andmake rotation more repeatable. In turn, all of these benefits will makefor a faster procedure with a higher success rate.

[0071] The sheath 111 accomplishes a high rotation ratio by using aspiral wound, multiple-wire, stainless steel, flexible shaft, with anoutside diameter of slightly less than the inside diameter of theworking channel of the endoscope. Because the sheath 111 is made of amultiple-wire configuration, it is soft and bendable, yet rigid inrotation. In other words, the sheath 111 is flexible enough to bemanipulated through a flexible endoscope, but has a very low angle oftwist about its central axis.

[0072] In the third function of the sheath 111, it acts as a componentof the mechanism by which the clip 101 is released. The outer sleeve112, which is rigidly attached to the sheath 111 by methods known in theprior art (e.g. adhesives, welding, swaging, etc.), is made of a rigidtube, with two retainer cut-outs (not shown), situated 180° apart fromeach other. These retainer cut-outs house the two tabs 118, 119 (FIG. 6)of the retainer 110. As the control wire 108 is actuated, drawing theclip 101 back into the lock sleeve 113, the retainer release 109 forcesthe retainer 110 to be disengaged from the outer sleeve 112.

[0073]FIG. 2 shows the clip 101 in the closed position but prior torelease of the j-hook 107. In the closed, locked position shown in FIG.2, lock hole 104 of clip leg 102 is engaged by lock pawl 114, and lockhole 105 of clip leg 103 is engaged by lock pawl 115. The fit betweenthe lock sleeve 113 and outer sleeve 112 is such that the lock sleeve113 (and therefore the clip 101) will easily release from the outersleeve 112 once the j-hook 107 has been straightened and the retainerdisengaged from the outer sleeve 112.

[0074] The clip 101, shown in FIG. 3, is manufactured of a single pieceof stainless steel, or any suitable biocompatible material, and is bentinto a two-legged geometry. The clip legs 102 and 103 have a rectangularcross section of approximately 0.06 inches by 0.01 inches and areapproximately 0.50 inches in length. The profile of the legs servesthree purposes: first, the distal portion grasps the tissue during theprocedure; second, the distal portion acts as the compression mechanismto hold the clip in place after deployment; and third, the profilebetween the distal grasping portion and the proximal end will interfacewith the lock pawls (not shown), via lock hole 104 in clip leg 102 andlock hole 105 in clip leg 103. The interface between the lock holes andthe lock pawls creates the mechanical lock that will keep the clip 101closed after deployment. The proximal end of the clip 101 is formed witha cut-out 106 into which the j-hook (FIG. 2) is attached.

[0075] The lock sleeve 113 shown in FIG. 4 consists of a tubularproximal section, which fits into the distal end of the outer sleeve112. Retainer hole 116 and opposite retainer hole (not shown) in thelock sleeve 113 receive the retainer tabs 118, 119 (FIG. 6). The distalend of the lock sleeve 113 has a lock sleeve cut-out 117 slightly largerthan the cross section of the clip legs (FIG. 3). As the clip leg arepulled through cut-out 117, the clip legs are compressed toward eachother, thus compressing the tissue (not shown) situated between the cliplegs. The cut-out 117 has lock pawls 114 and 115, which align with thetwo lock holes (FIG. 3) in the clip legs. After the desired tissuepurchase has been acquired, the clip can be pulled back far enough toengage the lock pawls 114 and 115 into the two lock holes.

[0076] Forming the end of the control wire 108 into a j-hook 107 makes afrangible link shown in FIG. 5. This relatively simple configurationeliminates extraneous components that take up space and complicate theassembly. The control wire 108 is bent such that it wraps around theproximal end of the clip (FIG. 3), through a cut-out (FIG. 3). Anotherbend in the wire, proximal to the j-hook 107, acts as a retainer release109. The retainer release 109 operates to release the retainer 110 (FIG.6) from the lock sleeve 113 (FIG. 4). As the control wire 108 isactuated and the clip is locked into the lock sleeve, the retainerrelease 109 pulls the retainer 110 back, disengaging the retainer tabs118, 119 from the two retainer holes 116 (FIG. 4) in which the retainernormally resides. After this disengagement is complete, the j-hook 107is then straightened by force, in turn releasing the clip. The j-hook107 is able to deform to a straightened position (i.e. release) at apredetermined tensile load, which is slightly greater than the loadrequired to grasp the tissue (not shown), compress the tissue, andengage the lock pawls (FIG. 4) in the lock holes (FIG. 3).

[0077] The control wire 108 shown in FIG. 6 is a simple stainless steelwire used to actuate the clip 101 via a handle (FIG. 7), at the proximalend of the sheath (FIG. 1). In this embodiment of the invention, thefrangible link (the j-hook 107) is formed in the distal end of thecontrol wire 108 as a one-piece design. The proximal end of the controlwire 108 is terminated inside the handle. The control wire 108 also hasthe retainer release 109 formed in it, behind the j-hook 107. Theretainer release 109 causes the outer sleeve (FIG. 1) to disengage fromthe retainer 110. This is done sequentially, after the lock holes (FIG.3) in the clip 101 have engaged the lock sleeve (FIG. 4). After the lockholes engage the lock sleeve, tensile force applied to control wire 108first straightens j-hook 107 so that j-hook 107 releases from cut-out106, then retainer release 109 engages and deforms retainer 110 so thatretainer tabs 118 and 119 disengage from the outer sleeve (FIG. 1) andthe lock sleeve (FIG. 4). Alternatively, retainer release 109 couldengage and deform retainer 110 before j-hook 106 straightens anddisengages from cut-out 106.

[0078] The handle shown in FIG. 7 is attached to the proximal end of thesheath 111 at a sheath-handle attachment point 120. The handleconfiguration is unlike a handle found on conventional endoscopicforceps known in the prior art. The handle provides a mechanism by whichthe amount of linear actuation required in the handle body 121 isgreater than that which is translated to the tip of the device (FIG. 1).In other words, actuation of the activator or handle lever 122 of 1.00inch in turn may only move the clip (FIG. 3) by 0.10 inch. This featureallows for a more tactile feel when placing the clip on the vessel (notshown). In effect, very subtle amounts of movement in the clip can beaccomplished by more exaggerated, less precise movements of theoperator's hand. This is accomplished because the activator or lever 122pivots about a pivot point 123 that is close to the attachment point 124of the control wire 125.

[0079] An alternative embodiment of the device may be made up of clipswith more than two legs. FIGS. 8A through 8E show a clip with four legs.FIG. 8A shows a view from the side, showing clip legs 801. Thisembodiment could be actuated and released in the same way the previousembodiment is activated and released, through a clip locking mechanism802. The use of a control wire (not shown) would actuate themultiple-legged clip in and out of an outer sleeve 803 until such timethat the operator desires to release the clip. Alternatively, actuationof the control wire might move the outer sleeve 803 in and out over themultiple-legged clip to open and close the clip legs 801, until suchtime that the operator desires to release the clip. FIG. 8B shows thefour-legged clip of FIG. 8A from the perspective of the targeted tissuelooking proximally. The four clip legs 801 are shown in an open positionand are situated at 900 from each other. FIG. 8C shows a profile view ofa single clip leg 801. FIG. 8D shows a view along the axis of cliplocking mechanism 802. FIG. 8E shows another view of a four-legged clipwith clip legs 801 and clip locking mechanism 802.

[0080]FIG. 8F shows alternative side profiles of the clip geometry. Useof such geometries in a clip with two or more legs allows for improvedgrasping ability in different situations. Given the large variation intissue thickness and tissue strength, it is likely that different clipprofiles would excel in different procedures. FIG. 8G shows alternativeend profiles of the clip geometry. As with the varying side profiles,different end profiles would provide a broader range of graspingcapabilities.

[0081]FIGS. 9A and 9B illustrate an alternative embodiment of the deviceusing a different method to lock the clip in the closed position. Thisalternative method uses an expanded coil spring 901 released over theoutside of the clip legs 904 and 905 to lock the clip legs 904 and 905closed. FIG. 9A shows this embodiment in a predeployment state. FIG. 9Ashows a stretched coil spring 901, twisted to a diameter larger thanthat of the relaxed state of coil spring 901. Stretched coil spring 901is placed over a rigid tube 903 at the distal end of the clip device.Within this rigid tube 903, the clip legs 904 and 905 are free to movein and out (in a manner similar to the manner described for the previousembodiments), between the opened and closed position via a control wire(not shown). When the desired clip location has been achieved, thesheath 902 is used to push the coil spring 901 off of the rigid tube903, onto the clip legs 904 and 905, as shown in FIG. 9B. The inwardradial forces present in the recovered coil spring 901 act to keep theclip legs 904 and 905 compressed.

[0082]FIGS. 10A and 10B illustrate another alternative embodiment. Inthis embodiment, a flexible linkage 1002 and pill 1003 are used to lockthe clip legs 1001. In this embodiment the clip legs 1001 are actuatedvia a control wire 1006, as described in previous embodiments. However,in this embodiment, the clip legs are not closed by pulling the cliplegs 1001 through some feature smaller than the open clip. Instead theclip legs 1001 are closed by drawing the two flexible links 1002proximally, in the direction of the control wire 1006, while acompressive force is applied to the base of the clip legs 1001 by arigid sheath (not shown). This in turn pulls the legs of the clip towardeach other. FIG. 10A shows the clip legs 1001 in an open position. FIG.10B shows the clip legs in a closed position. The clip legs 1001 arelocked in a closed position when the pill 1003, located at the center ofthe flexible linkage 1002, is drawn through a one way hole 1004 in thecenter of the clip legs 1001. The one way hole 1004 is tapered, with adiameter slightly larger than the diameter of the pill 1003 on itsdistal side and a diameter smaller than the diameter of the pill 1003 onits proximal side. The pill stretches the material around the hole 1004as it passes through moving proximally. Alternatively, the pill 1003itself can be made of an elastic material and would deform slightlywhile passing proximally through hole 1004. This funneling effect of thepill 1003 through the hole 1004 only allows the pill 1003 to easily passthrough in the locking direction. This locking action is maintainedafter the clip is released by positioning the frangible link 1005 in aproximal direction on control wire 1006 from the pill 1003, thusmaintaining tissue compression. In this embodiment the frangible link1005 is a taper in control wire 1006, enabling the link to be broken ata specific position (proximal from the pill 1003) with a predeterminedtensile load.

[0083] One alternative to the j-hook type frangible link previouslydescribed is shown in FIG. 11. This embodiment uses a threaded fittingthat is a combination of a male thread 1103 and a female hub 1102 toattach the control wire (not shown) to the clip 1001. The clip 1001 canbe actuated from the opened position (not shown) to the closed position(shown) as described in previous embodiments. In this embodiment, thelock sleeve 1105 is shorter and engages dimples 1106. After the lesion(not shown) is properly targeted, the clip 1101 can be released. Theclip 1101 is released when a predetermined tensile load is applied tothe male thread 1103, in a similar fashion to the predetermined tensileload applied to straighten the j-hook. This force causes the male thread1103 to detach from the female hub 1102. The female hub 1102 may beconstructed of a spiral wound wire component with a pitch equal to thethread pitch formed to make the male thread 1103. The fit of thethreaded components is such that the predetermined force will overcomethe engaged threads of the male thread 1103 and the female hub 1102,causing them to separate, or “strip” away from one another.

[0084] Another alternative to the j-hook type frangible link is shown inFIGS. 12A and 12B. This embodiment uses a ball 1202 fitting into asocket, where the socket is defined by socket tabs 1203, to attach thecontrol wire 1207 to the clip 1201. An outer sleeve 1204 is attached byway of a breakaway connection (not shown) to the sheath 1206. Thisbreakaway connection may be a light interference fit, or a lightadhesive joint. The breakaway connection must be weak enough that whenthe sheath 1206 is pulled back through the working channel (not shown)of the endoscope (not shown), the outer sleeve 1204 will release withthe clip 1201. The clip 1201 is released when the socket tabs 1203 atthe proximal end of the clip 1201 are aligned with cut-outs 1205 in theouter sleeve 1204. These cut-outs 1205 act as a relief area into whichthe socket tabs 1203 can be deformed when a predetermined tensile loadis applied to them via the ball 1202 formed on the end of the controlwire 1207. The outer sleeve 1204 is released with clip 1201 so that theclip 1201 remains locked after deployment.

[0085] Another alternative to the j-hook type frangible link is shown inFIGS. 13A, 13B and 13C. All the figures show the clip 1301 in a closedand locked state. FIG. 13A shows the clip 1301 in a closed position butbefore it is released and shows a portion of outer sleeve 1303 cut awayto show the internal workings of the clip mechanism. FIGS. 13B and 13Cshow the clip 1301 after being released. In this embodiment, theactuation is still performed via a control wire 1304, however thedirection of action is reversed. As the control wire 1304 is pushedforward, the clip 1301 is closed by the advancement of outer sleeve 1303and lock ring 1302 over the clip legs. The locking sleeve 1302 and clipgeometry, including dimples 1306, is the same as that explained in theembodiment of FIG. 11.

[0086] A difference between the embodiment shown in FIGS. 13A, 13B and13C and the prior embodiments is the mechanism by which the clip 1301 isreleased 1033 from the rest of the device. An interference fit betweenthe outer sleeve 1303, sheath 1305, and male threaded hub 1308 iscreated when the device is assembled. The distal end of the sheath 1305,in its manufactured (but unassembled) state, has an outside diametergreater than the inside diameter of the outer sleeve 1303. When theouter sleeve 1303 and sheath 1305 are assembled together part of theinterference fit is created. The distal end of the sheath 1305, again inits manufactured (unassembled) state, has an inside diameter greaterthan the diameter of the male threaded hub 1308. During assembly, as thedistal end of the sheath 1305 is compressed to fit inside the outersleeve 1303, it is compressed down onto the male threaded hub 1308 tocreate a sandwich of the sheath 1305 between the male threaded hub 1308on the inside and the outer sleeve 1303 on the outside. During themedical procedure, at the time the operator wishes to release the clip1301, this interference fit is overcome. The interference fit isovercome by advancing the outer sleeve 1303 so far forward, by creatinga compressive force in the control wire 1304 in opposition to a tensileforce on the sheath 1305, that the outer sleeve 1303 is no longer incontact with the distal end of the sheath 1305.

[0087] The outer sleeve 1303 and the control wire 1304 serve twopurposes in this embodiment. The outer sleeve 1303 and the control wire1304 supply the closing force to the clip 1301. In FIGS. 13A, 13B, and13C, a lock ring 1302 is used to maintain the closing force on the cliplegs 1307. The outer sleeve 1303 and the control wire 1304 also act askey components of the release mechanism. As previously described, oncethe outer sleeve 1303 is moved to its forward-most position, the end ofthe sheath 1305 is no longer contained within the outer sleeve 1303, andis free to separate from the male threaded hub 1308. The sheath 1305 isfree to release because of the manner in which the distal end of thesheath 1305 is manufactured/assembled.

[0088] When the outer sleeve 1303 is advanced forward, allowing thedistal end of the sheath 1305 to be free, the distal end of the sheath1305 expands to its original, manufactured state. This allows the insideof the sheath 1305 to release from the male threaded hub 1308. The malethreaded hub 1308, and thus the clip 1301, are now free from the sheath1305 and the rest of the delivery device. As shown in FIG. 13C, theouter sleeve 1303 remains connected to the control wire 1304 atconnection point 1310, and both can be removed with the sheath 1305. Thedistal portion of control wire 1304 is bent towards, and connects with,outer sleeve 1303 at connection point 1310. The distal portion ofcontrol wire 1304 passes male threaded hub 1308 during deploymentthrough slot 1309 in male threaded hub 1308.

[0089]FIGS. 14A, 14B, and 14C show an alternative embodiment of thepresent invention. In the embodiment of FIGS. 14A, 14B, and 14C, therelaxed state of the clip is closed, and it is forced open and allowedto close naturally. FIG. 14A shows a side view of the clip 1401 in aclosed, pre-released state, and FIG. 14B shows an edge view of the clip1401 in a closed, pre-released state. In this embodiment, because theclip 1401 is manufactured such that the clip legs 1407 are naturallyclosed, the primary function of the control wire 1406 is changed fromhaving to close the clip 1401, to having to open the clip 1401. The clip1401 is manufactured in a generally x-shaped geometry, where each tab1403 at the proximal end of the clip 1401 controls a clip leg 1407opposite at the distal end of the clip 1401. The action/reaction of theclip 1401 is similar to that of a common clothes pin. As the tabs 1403are brought together, the clip legs 1407 are spread apart. As the tabs1403 are released, the clip legs 1407 come together. A u-ring 1402attached to the end of the control wire 1406 is used to bring the tabs1403 together, thus opening the clip 1401. Pulling on the control wire1406 pulls the u-ring 1402 into contact with tabs 1403 creating acompressive force to open clip legs 1407 because clip 1401 is positionedagainst fulcrum point 1408. Advancing control wire 1406 advances u-ring1402, thereby removing the compressive force on tabs 1403 and allowingclip legs 1407 to close. Advancing control wire 1406 further to adeployment position pushes u-ring 1402 against clip legs 1407, causingclip 1401 to move out of outer sleeve 1404 into a deployed state.

[0090] The control wire 1406 is constructed of material having a shapememory, and the distal end of the control wire 1406, where the u-ring1402 is attached, is pre-bent to one side. While a minimum tensionexists in control wire 1406, the u-ring remains around the constriction.However, when the desired location for the clip 1401 has been achieved,and the clip tabs 1403 have been advanced beyond outer sleeve 1404, thecontrol wire 1406 can be advanced to its most distal position. Becausethe control wire 1406 is pre-bent, as it is advanced the u-ring 1402becomes disengaged from the clip 1401 when the tension in control wire1406 falls below a pre-determined amount, as shown in FIG. 14C. Thisallows the clip 1401 to be released.

[0091]FIGS. 15A, 15B, 15C, and 15D show another embodiment in which theclip is manufactured in a naturally closed position. FIG. 15A shows thedistal end of medical device 1509 with the clip 1501 in a closedposition before deployment. FIG. 15B shows only the clip 1501 in aclosed position. FIG. 15C shows the clip 1501 in an open position. FIG.15D shows the device after the clip is released. The clip 1501 is shapedsuch that, as the control wire 1503 is pulled in a proximal direction,the clip legs 1508 are forced apart from one another. This isaccomplished using a pill 1502 attached to the end of the control wire1503 as explained in previous embodiments. Two rigid arms 1504, locatedbetween the clip legs 1508, translate the tensile force on the controlwire 1503 to an outward radial force on the clip legs 1508. When thedesired location for the clip 1501 has been achieved, the control wire1503 can be advanced to its most distal position. Because the controlwire 1503 is constructed of material that has a shape memory, andbecause the control wire 1503 is pre-bent close to the pill 1502, as thecontrol wire 1503 is advanced, the pill 1502 becomes disengaged from thepill well 1507. When the pill 1502 moves out and away from the pill well1507, the clip 1501 is released and disengages from the control wire1502, the sheath 1506, and the outer sleeve 1505.

[0092]FIGS. 16A, 16B, 16C, 16D, and 16E show another embodiment in whichthe clip is manufactured in a naturally closed position. FIG. 16A showsthe clip 1607 in a closed, predeployed, state. FIG. 16B shows a sideview of one clip leg 1601 with the pill 1603 still resting in pill well1604. FIG. 16C shows an edge view of one clip leg 1601 with the pill1603 still resting in pill well 1604. FIG. 16D shows a clip 1607 in anopen position. FIG. 16E shows a clip 1607 in a closed position. Thisembodiment uses two control wires 1605. Alternatively, a branchedcontrol wire may be used. By using a branched control wire or twocontrol wires 1605, the force can be transmitted to a point further awayfrom the fulcrum (bending point) 1606 of the clip 1607. The greater thisdistance, the lesser the force required to open the clip legs 1601. Asin the previous embodiments, the control wires 1605 are disengaged fromthe clip 1607 by pushing them forward. This action disengages the pills1603 from the clip 1607 by moving the pills 1603 out of pill wells 1604.The control wires 1605 are made from a material with a shape memory, sothat when freed from pill wells 1604, the pills 1603 move away from thepill wells 1604, and the clip 1607 is deployed.

[0093] Another embodiment is shown in FIGS. 17A and 17B. In thisembodiment, the control wire or wires 1701 are routed to gain mechanicaladvantage. In this embodiment, the clip 1702 is naturally closed, withthe control wire(s) 1701 routed to leverage points 1704 further awayfrom the fulcrum (bending point) 1705 of the clip 1702. In thisembodiment, the control wire(s) 1701 are looped around pins positionedat leverage points 1704 at the ends of the clip legs 1706. The controlwire(s) 1701 are then routed to a point at the proximal end of the clip.The control wire(s) 1701 are then terminated at this point. For ease ofmanufacture, the control wire(s) 1701 could essentially be one,continuous wire, with both ends terminated in the handle (not shown). Torelease the clip 1702, one end of control wire 1701 could be detachedfrom the handle and pulled free from the clip 1702. Because the controlwire 1701 is only wrapped around pins positioned at leverage points 1704on the clip 1702, by pulling on one end of control wire 1701, controlwire 1701 could be easily detached when the desired location for clip1702 has been achieved by continuing to pull on one end of control wire1701 until all of control wire 1701 has been detached from the clip1702.

[0094]FIGS. 18A, 18B, 18C, 18D, 18E, and 18F show an embodiment of aclip which incorporates the natural compressive forces present in asimple elastic band (or o-ring) 1802 to hold the clip legs 1801 in theclosed position. FIG. 18A shows two clip legs 1801 in a disassembledstate. FIG. 18B shows a clip with the control wire 1803 engaging asecond elastic band 1804 to open clip legs 1801. In this embodiment, thecontrol wire 1803 is attached to the proximal end of the clip legs 1801via a frangible link. In this embodiment, the frangible link is a secondelastic band (or o-ring) 1804 that will deform as the control wire 1803is pulled back. In this embodiment, the clip is housed in the end of asheath 1806 such that, as the control wire 1803 is pulled back, thesecond elastic band 1804 delivers an increasing compressive force to theclip legs 1801 proximal to a pin joint 1805, thereby causing the cliplegs 1801 distal from the pin joint to open against the compressiveforce of elastic band 1802. In this manner, the clip legs 1801 move toan open position, as shown in FIG. 18B. FIG. 18C shows the clip in aclosed, predeployed state. FIG. 18D shows a profile view of clip legs1801, and FIG. 18E shows an end-on view of clip legs 1801 within sheath1806. FIG. 18F shows a close-up view of clip legs 1801 without firstelastic band 1802 but showing band slots 1809. FIG. 18F shows secondelastic band 1804 resting over nubs 1807 and coupled to control wire1803. When the desired clip location has been achieved, the secondelastic band 1804, which makes up the frangible link, is overcome bypulling the control wire 1803 to its most proximal position. This hasthe effect of breaking second elastic band 1804. Alternatively, secondelastic band 1804 could be designed to release over nubs 1807. In athird alternative, after placing clip legs 1801 in the desired location,control wire 1803 can be released so that elastic band 1802 again closesclip legs 1801. In this third embodiment, control wire 1803 is made of asuitable material, such as a shape memory material, and has a bend inthe distal region such that moving control wire 1803 to a maximum distalposition acts to unhook hook 1808 from second elastic band 1804.

[0095]FIGS. 19A, 19B, and 19C show another embodiment of the inventionutilizing a naturally closed clip. Clip 1901 is held in the naturallyclosed position by a torsion spring 1903. The clip 1901 is actuated fromthe closed to the opened position in a different way than priorembodiments. A plunger 1904, located within the outer sleeve 1905 at theend of the sheath (not shown), is used to push on the tabs 1906 on theproximal end of the clip 1901. The tabs 1906 are pushed through anopening 1907 in the end of the outer sleeve 1905. This moves tabs 1906close together, in turn moving the clip legs 1902 to the open position.When the desired clip location has been achieved, the clip 1901 can bereleased by advancing the plunger 1904 to its most distal position. FIG.19B shows the clip 1901 from a profile view. FIG. 19C shows a singleclip leg 1902 and connection point 1908 for pivotally connecting cliplegs 1902 to each other.

[0096]FIGS. 20A, 20B, and 20C describe the embodiment of a three-leggedclip and delivery device. The clip 2001 is manufactured to be in thenaturally open position. The clip 2001 is characterized by male threads2002 on its outer surface. The delivery device consists of a sheath 2003similar to those described in previous embodiments. An inner sleeve 2004located within the distal end of the sheath 2003 is used to actuate theclip 2001 from its naturally open position to the closed position. Theinner sleeve 2004 has female threads (not shown) on its inside diameter.A control wire (not shown) is used in this device to transmit rotationalforce rather than tensile/compressive force. Rotating the sheath 2003with respect to the control wire, with the handle (not shown) actuatesthe clip 2001. This rotation force is translated to the female threads,causing them to be threaded onto the clip 2001. As the naturally openclip legs 2005 move toward the inner sleeve 2004, the clip legs 2005 areclosed. The clip 2001 and inner sleeve 2004 are released from the sheath2003 via some form of frangible link (not shown) as described in theprevious embodiments. FIG. 20A shows the clip legs 2005 and inner sleeve2004 from the perspective of the target area. FIG. 20C shows the sizerelationship between the female threads on the inner sleeve 2004 and themale threads 2002 on the clip 2001.

[0097]FIG. 21 shows another embodiment of a naturally open clip anddelivery device. FIG. 21 shows the distal portion of the medical devicewith a portion of the outer sleeve 2102 cut away to show the innermechanics of the clipping device. The delivery device consists of asheath 2103 similar to those described in previous embodiments. The clip2101 is actuated from the open to the closed position via a control wire2104, as described in the primary embodiment. A frangible link isimplemented in this embodiment by a breakable link 2105. In thisembodiment the lock sleeve is eliminated. Eliminating the lock sleevereduces the number of components and the overall size of the device. Inthis embodiment the outer sleeve 2102 is used to hold the clip 2101 inthe closed position. Therefore, the outer sleeve 2102 must be deployedfrom the sheath 2103 when the clip 2101 is released. To create apositive mechanical lock between the clip 2101 and outer sleeve 2102,the clip 2101 has two deformable tabs 2106 formed in its proximal end.When the desired tissue purchase has been accomplished, the control wire2104 is further actuated by the handle (not shown) so that the tabs 2106reach a position where they are in the same plane as the cut-outs 2107in the outer sleeve 2102. Once the tabs 2106 have reached this point,further actuation of the control wire 2104 forces the tabs 2106 todeform through the cut-outs 2107 in the outer sleeve 2102. As in thefirst embodiment, a retainer 2108 is used to create a mechanical lockbetween the sheath 2103 and outer sleeve 2102. In this embodiment theretainer 2108 passes through slots 2109 in the outer sleeve 2102 and asheath connector 2110. The sheath connector 2110 is simply a rigidconnector, applied to the end of the sheath 2103 by some means known inthe art (e.g. welding, adhesive, swaging, etc.). As the tabs 2106 becomeengaged, a tensile load in the control wire 2104 is translated to thebreakable link 2105. At a predetermined tensile load, the breakable link2105 breaks. As the control wire 2104 is further actuated, a distalportion of control wire 2104, which is preformed into a shape that willfunction as a retainer release, engages the retainer 2108. The retainer2108 is pulled from the outer sleeve 2102 by the control wire 2104, in asimilar manner to that described in the primary embodiment. Once this isdone, the sheath connector 2110 (and therefore the sheath 2103) isreleased from the outer sleeve 2102.

[0098] The materials utilized in construction of the clip of the presentinvention include many bio-compatible materials (metals, polymers,composites, etc.). A stainless steel grade material, which offers goodspring properties, may be used. The clip can also be coated, or plated,with a material like gold to improve radiopacity.

[0099] The lock sleeve, lock pawls, retainer and outer sleeve may becomprised of any of the same materials as the clip component. Forexample, stainless steel may be used.

[0100] The control wire in the first embodiment may be a stainless steelwire. Because the wire must offer sufficient strength in both tensionand compression, the material properties of the wire are important tothe functionality of the device. Also, the end of the wire, where thej-hook is formed, must deform when a predetermined tensile load isapplied. The device's ability to release the clip is dependent on thisproperty. Other embodiments of the device may incorporate a two (ormore) piece wire so that certain sections of the wire have differentmaterial properties or geometries. Different material properties orgeometries could allow for more control over how and when the wiredetaches from the distal tip of the device. This could also beaccomplished by several other methods, as well. For example, localizedheat treating and/or coatings could be used along portions of the wireto alter the material characteristics. Additionally, some embodiments ofthe present invention require a control wire constructed of a materialwith a shape memory.

[0101] The sheath, in the first embodiment, is made up of several round,stainless steel wires, wound in a helical pattern to create a hollow,semi-rigid shaft. Sheaths made in this fashion are well known in theprior art. In other embodiments, the sheath could be made up ofnon-round wires. Other embodiments may be made up of one or more wiresformed in a pattern other than a single helix, as in the firstembodiment. A multiple helix or braided pattern may be used. The sheathmay also be coated with a protective coating of Polytetrafluoroethylene(PTFE), or similar materials. The use of such coatings could be used toalter the flexibility of the shaft. Such coatings could also be used toincrease the lubricity (decrease the coefficient of friction) betweenthe endoscope working channel and the device. Similar materials couldalso be used to encapsulate the sheath's base material. This wouldcreate a matrix material, providing a combination of material propertiesnot feasible with one single material. Other embodiments may usematerials other than stainless steel as the base material. Materialssuch as titanium, nitinol, and/or nylon fibers may be incorporated.

[0102] A method of using the endoscopic hemostatic clipping device isprovided. The method involves placing an endoscope in a body cavity asis known in the art. The device provided herein is then inserted throughthe endoscope. At the distal end, the endoscope is positioned near thetarget area. As noted above, the target area may be a lesion, a bleedingulcer, a tumor, other abnormality, or any number of other tissues to bepinched, marked, tagged, or to which the operator wishes to apply apinching pressure for whatever reason. The device provided is thenpositioned so that the clip legs embrace the target area, then theactuator is activated to close the clip legs. The success or failure ofthe application of pressure can be reviewed through the opticalcomponents provided separately in the endoscope. If the pinching isunsuccessful or only marginally successful, the clip legs of the devicemay be opened by reversing the actuation of the activator.Alternatively, if the pinching is successful, and the operator wishes todeploy the device, the actuator is fully activated, or the alternativedeployment activator is activated. Finally, the remaining portion of themedical device and the endoscope are removed from the body.

[0103] It will be obvious to those skilled in the art, having regard tothis disclosure, that other variations on this invention beyond thosespecifically exemplified here may be made. These variations include, butare not limited to, different combinations of clips, closing mechanisms,locking mechanisms, frangible links, and clip leg formations. Suchvariations are, however, to be considered as coming within the scope ofthis invention as limited solely by the following claims.

What is claimed is:
 1. A medical device for causing the hemostasis of ablood vessel for use through an endoscope, said medical devicecomprising: a clip, the clip having at least two clip legs; a controlwire able to be coupled to the clip, the control wire reversiblyoperable both to open the at least two clip legs and to close the atleast two clip legs, the control wire uncouplable from the clip; anaxially rigid sheath enclosing the control wire, the sheath able tocommunicate a first force opposing a second force of the control wire; ahandle coupled to the axially rigid sheath; and an actuator coupled tothe control wire, the control wire engageable by the actuator to openthe at least two clip legs, to close the at least two clip legs, and touncouple the control wire from the clip.
 2. The medical device of claim1, wherein: the actuator comprises a lever; and the lever able totransmit a fraction of an amount of an operator's movement of the leverinto linear movement of the control wire, the fraction being less thanone.
 3. The medical device of claim 1, wherein: the control wire is ableto be coupled to the clip by a j-hook; the j-hook is able to bestraightened by a first predetermined tensile force; and when the j-hookis straightened, the control wire uncouples from the clip.
 4. Themedical device of claim 1, wherein: the control wire is able to becoupled to the clip by a breakable link; the breakable link is able tobe broken by a first predetermined tensile force; and when the breakablelink is broken, the control wire uncouples from the clip.
 5. The medicaldevice of claim 1, wherein: the control wire is able to be coupled tothe clip by a male thread coupled to a female hub; the male thread andthe female hub are able to be stripped apart by a first predeterminedtensile force; and when the male thread and the female hub are strippedapart, the control wire uncouples from the clip.
 6. The medical deviceof claim 1, wherein: the control wire is able to be coupled to the clipby at least one ball on the control wire being situated within at leastone socket on the clip; the at least one ball on the control wireremovable from the at least one socket; and when the ball is removedfrom the socket, the control wire uncouples from the clip.
 7. Themedical device of claim 6, wherein: the socket is formed by at least twotabs; each of the at least two tabs deformable by the ball into acorresponding cut-out in an outer sleeve at a predetermined tensileforce; and when the at least two tabs are deformed, the control wireuncouples from the clip.
 8. The medical device of claim 1, wherein: thecontrol wire is able to be coupled to the clip by at least one u-ringattached to the control wire situated around a constriction in the clip;the at least one u-ring removable from around the constriction; and whenthe u-ring is removed from around the constriction, the control wireuncouples from the clip.
 9. The medical device of claim 8, wherein: thecontrol wire comprises a shape memory material at least on a distalportion of the control wire; and when the control wire relaxes, the atleast one u-ring moves away from around the constriction, and thecontrol wire uncouples from the clip.
 10. The medical device of claim 1,wherein: the control wire is able to be coupled to the clip by at leastone pill on the control wire being situated within at least one pillwell on the clip; the at least one pill removable from the at least onepill well; and when the pill is removed from the pill well, the controlwire uncouples from the clip.
 11. The medical device of claim 10,wherein: the control wire comprises a shape memory material at least ona distal portion of the control wire; and when the control wire relaxes,the at least one pill moves out of the at least one well, and thecontrol wire uncouples from the clip.
 12. The medical device of claim 1,wherein: the clip comprises at least one pin; the control wire is ableto be coupled to the clip by being threaded around the at least one pin;and when the control wire unthreads from around the at least one pin,the control wire uncouples from the clip.
 13. The medical device ofclaim 1, wherein the control wire is able to couple to the clip by anelastic band.
 14. The medical device of claim 13, wherein breaking theelastic band is able to uncouple the control wire from the clip.
 15. Themedical device of claim 13, wherein: the control wire comprises a hook;the hook is able to engage the elastic band; and the control wire ismovable distally to unhook and disengage the control wire from theelastic band, thereby uncoupling the control wire from the clip.
 16. Themedical device of claim 1, further comprising a lock sleeve, wherein thecontrol wire is able to be pulled in a proximal direction to pull theclip through the lock sleeve, thereby closing the clip legs.
 17. Themedical device of claim 16, wherein the control wire is able to bepushed in a distal direction to push the clip out of the lock sleeve,thereby opening the clip legs.
 18. The medical device of claim 1,further comprising a lock sleeve, wherein the outer sleeve is able to bepushed in a distal direction to push the lock sleeve over the clip,thereby closing the clip legs.
 19. The medical device of claim 18,wherein the outer sleeve is able to be pulled in a proximal direction topull the lock sleeve away from around the chip, thereby opening the cliplegs.
 20. The medical device of claim 16 further comprising: a retainer,the retainer releasably coupled to the lock sleeve; and a retainerrelease arrangement, the retainer release arrangement able to engage theretainer to uncouple the retainer from the lock sleeve.
 21. The medicaldevice of claim 1, further comprising a lock arrangement for locking theat least two clip legs in a closed position.
 22. The medical device ofclaim 21, wherein the lock arrangement comprises: at least two lockholes, the number of lock holes corresponding to the number of cliplegs, each of the at least two lock holes situated on a correspondingclip leg; a lock sleeve; and at least two lock pawls, the number of lockpawls corresponding to the number of clip legs, each of the at least twolock pawls situated on the lock sleeve; wherein the at least two lockholes are engageable by the at least two lock pawls.
 23. The medicaldevice of claim 21, wherein the lock arrangement locking the at leasttwo clip legs in a closed position comprises: a rigid tube; a coiledspring, the coiled spring arranged on the rigid tube, the rigid tubesupporting the coiled spring in an expanded position, the coiled springencircling the rigid tube on a distal end; and a coil engagingarrangement arranged on the clip legs; wherein the rigid tube isengageable by the control wire, the rigid tube movable proximally withrespect to the sheath, the coiled spring engageable by the sheath tocause the coiled spring to slide off the rigid tube onto the clip legs,thereby causing the coiled spring to engage the coil engagingarrangement on the clip legs to lock the clip legs in a closed position.24. The medical device of claim 21, wherein the lock arrangement lockingthe at least two clip legs in a closed position comprises: at least onepill situated on a distal end of the control wire; and at least one lockhole, wherein the control wire passes through at least one lock hole;wherein the at least one pill is movable by the control wire proximallythrough the at least one lock hole; and wherein once the at least onepill moves proximally through the at least one lock hole, the at leastone pill is not movable distally through the at least one lock hole. 25.The medical device of claim 21, wherein the lock arrangement locking theat least two clip legs in a closed position comprises: a lock sleeve,the lock sleeve situated radially outward from the at least two cliplegs; and at least two dimples, the number of dimples corresponding tothe number of clip legs, each of the dimples situated on a correspondingclip leg; wherein the at least two dimples are engageable by the locksleeve.
 26. The medical device of claim 21, wherein the lock arrangementlocking the at least two clip legs in a closed position comprises: atleast two deformable lock tabs, the number of deformable lock tabscorresponding to the number of clip legs, each of the at least twodeformable lock tabs situated on a proximal end of a corresponding clipleg; and at least two lock holes, the number of lock holes correspondingto the number of clip legs, each of the lock holes situated on a locksleeve; wherein each of the at least two lock holes is engageable byeach of the at least two deformable lock tabs.
 27. The medical device ofclaim 1, wherein the axially rigid sheath is torsionally rigid, thesheath transmitting a rotational force from the handle to the clip at aratio of approximately 1 to
 1. 28. The medical device of claim 1,further comprising: at least two flexible links, the number of flexiblelinks corresponding to the number of clip legs, each of the at least twoflexible links extending inward radially from each corresponding clipleg to an axial position to connect to the control wire; wherein aproximal tensile force applied to the control wire translates to aradially inward tensile force to each of the at least two flexiblelinks, causing the clip to close.
 29. The medical device of claim 1,further comprising: a lock sleeve, the lock sleeve radially surroundingthe clip legs; wherein a distal compressive force applied to the locksleeve moves the lock sleeve relative to the at least two clip legs,causing the at least two clip legs to close.
 30. The medical device ofclaim 1, further comprising: an expanded spring arrangement, theexpanded spring arrangement situated distally from a pivot point on theat least two clip legs; wherein the spring arrangement is able to applya radially inward tensile force on the at least two clip legs to causethe at least two clip legs to close.
 31. The medical device of claim 1,further comprising: a compressed spring arrangement, the compressedspring arrangement situated proximally from a pivot point on the cliplegs; and at least two tabs, the number of tabs corresponding to thenumber of clip legs; wherein the compressed spring arrangement pushesradially outward on at least two tabs, the tabs translating the radiallyoutward force via the pivot point to a radially inward force at the atleast two clip legs, causing the at least two clip legs to close. 32.The medical device of claim 1, further comprising an elastic bandarrangement, the elastic band arrangement including: a first elasticband, the first elastic band situated distally from a pivot point andsituated radially outward from the at least two clip legs, wherein thefirst elastic band applies a radially inward force to the at least twoclip legs; and a second elastic band, the second elastic band situatedproximally from a pivot point and situated radially outward from atleast two tabs; wherein the second elastic band applies a radiallyinward force to the at least two tabs which translates via the pivotpoint to a radially outward force on the at least two clip legs; andwherein the control wire is uncouplably connected to the second elasticband and is able to increase the radially inward force applied by thesecond elastic band to the at least two tabs.
 33. The medical device ofclaim 1, further comprising: at least two rigid arms, the number ofrigid arms corresponding to the number of clip legs, each of the atleast two rigid arms extending outward radially from a central axialposition to a corresponding clip leg, the at least two rigid armsuncouplably connected to the control wire, the at least two rigid armsactivatable by the control wire to to apply an outward radial force tothe at least two clip legs; wherein the at least two clip legs areconstructed of a material that retains an original shape afterdeformation, the original shape of the at least two clip legs being aclosed position, the at least two clip legs elastically deformable to anopen position by the at least two rigid arms.
 34. The medical device ofclaim 1, wherein the at least two clip legs are constructed of amaterial that retains an original shape after deformation, the originalshape of the at least two clip legs being a closed position, the atleast two clip legs elastically deformable to an open position by thecontrol wire.
 35. The medical device of claim 1, wherein a proximaltensile force on the control wire is opposable by a distal compressiveforce on the outer sheath, the distal compressive force on the outersheath able to close and lock the at least two clip legs.
 36. Themedical device of claim 1, wherein a proximal tensile force on the outersheath is opposable by a distal compressive force on the control wire,the distal compressive force on the control wire able to close and lockthe at least two clip legs.
 37. The medical device of claim 1, wherein adistal termination of the control wire comprises a loop, wherein a firstend and a second end of the control wire terminate at the handle. 38.The medical device of claim 1, wherein a distal termination of thecontrol wire comprises: at least one pill; and at least one pill well,the number of pill wells corresponding to the number of pills; whereineach of the at least one pill is situated in the at least one pill well;and wherein the at least one pill is moveable out and away from the atleast one pill well.
 39. The medical device of claim 1, wherein a distaltermination of the control wire comprises: a u-ring; and a constrictionof the clip; wherein the u-ring is situated on the constriction of theclip and the u-ring is moveable out and away from the constriction. 40.The medical device of claim 1, wherein a distal termination of thecontrol wire comprises: a frangible link, wherein the frangible link isat least one of a wire reversibly deformed into a j-hook and a breakablelink, wherein the j-hook is able to be straightened by a firstpredetermined tensile force; and wherein the breakable link is able tobe broken by the first predetermined tensile force.
 41. The medicaldevice of claim 1, wherein a distal termination of the control wirecomprises a plunger, wherein the plunger ejects the clip from an outersleeve when a distal force is applied to the control wire.
 42. Themedical device of claim 1, wherein a distal termination of the controlwire comprises: a screw arrangement, wherein the handle is able to berotated to thread a base of the clip into a female thread situated on aradially inner side of an outer sleeve, the clip able to move proximallyand the at least two clip legs able to close when the base is threadedinto the outer sleeve.
 43. The medical device of claim 1, wherein thedevice is disposable.
 44. A medical device for causing the hemostasis ofa blood vessel for use through an endoscope, said medical devicecomprising: a clip, the clip having at least two clip legs; an outersleeve, the outer sleeve reversibly movable with respect to the clipboth to open the at least two clip legs and to close the at least twoclip legs; a control wire coupled to the outer sleeve for moving theouter sleeve relative to the clip: an axially rigid sheath enclosing thecontrol wire, the sheath couplable with, and uncouplable from, the clip;a handle coupled to the axially rigid sheath; and an actuator coupled tothe control wire, the control wire engageable by the actuator to movethe outer sleeve to open the at least two clip legs, to close the atleast two clip legs, and to uncouple the clip from the sheath.
 45. Amethod of providing and using a medical device to deploy a clip forcausing the hemostasis of a blood vessel, said method comprising: (i)providing a medical device comprising: a clip, wherein the clip has atleast two clip legs; a control wire coupled to the clip, the controlwire reversibly operable both to open the at least two clip legs and toclose the at least two clip legs, the control wire being uncouplablefrom the clip; an axially rigid sheath enclosing the control wire, thesheath able to communicate a force opposing a force of the control wire;a handle coupled to the axially rigid sheath; and an actuator coupled tothe control wire, the control wire engageable by the actuator to openthe at least two clip legs and to close the at least two clip legs andto uncouple the control wire from the clip; (ii) advancing the medicaldevice so that the clip is located at the desired deployment location;and (iii) moving the actuator to close the clip legs, and optionally toreopen and reclose the clip legs, and to uncouple the clip from thecontrol wire.